TEAT SEAL
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
04-04-2015
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Active ingredient:
CLOXACILLIN BENZATHINE, BISMUTH SUBNITRATE
Available from:
Cross Vetpharm Group Limited
ATC code:
QJ51CF02
INN (International Name):
CLOXACILLIN BENZATHINE, BISMUTH SUBNITRATE
Dosage:
600 mg/syringe
Pharmaceutical form:
Intramammary Infusion
Prescription type:
POM
Therapeutic group:
Bovine
Therapeutic area:
Cloxacillin
Therapeutic indications:
Antibacterial
Authorization status:
Authorised
Authorization date:
1997-10-01
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Teat Seal
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
TEAT SEAL 1:
INTRAMAMMARY SUSPENSION
ACTIVE SUBSTANCE
PER 3.6 G
Cloxacillin
(as Cloxacillin benzathine)
600 mg
TEAT SEAL 2:
INTRAMAMMARY OINTMENT
ACTIVE SUBSTANCES
PER 4 G
Bismuth subnitrate
2.6 g
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Teat Seal 1: Intramammary suspension. A white to off-white suspension.
Teat Seal 2: Intramammary ointment. A greyish-white ointment.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cows
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For routine use in cows at drying off, to treat existing infection of the udder caused by organisms sensitive to Cloxacillin
and to assist in preventing further infection during the dry cow period. This results in a reduction in the incidence of
subclinical mastitis in cows at calving and of clinical mastitis in the dry period and the subsequent lactation (for at least 60
day after calving).
4.3 CONTRAINDICATIONS
Do not use in the lactating cow.
Do not use within 28 days of the expected calving date.
Do not use within 3 days of the administration of any other intramammary preparations.
Do not use in known cases of hypersensitivity to the active ingredients.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 20/03/2015_
_CRN 7020461_
_page number: 1_
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Not applicable.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Care should be taken to avoid the contamination of the injector nozzle when the cap has been removed.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE MEDICINAL PRODUCT TO
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